MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW 15GADJ LEN; BIOPSY NEEDLES & TRAYS

Catalog Number DIN1515X

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Date 09/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Follow up submission will be completed post investigation or if additional information becomes available.

Event Description

The seal is open partially on the product pouch.

Event Description

The seal is open partially on the product pouch.

Manufacturer Narrative

Pr 589637 our manufacturing quality engineer received ten photos (10) for evaluation.It could be seen that the pouches are open on the sides, therefore, failure mode could be confirmed.A device history review was also performed for the reported lot numbers manufactured confirming procedural and functional requirements need for the product to be released were met.Although reported failure was confirmed through visual analysis a root cause could not be determined through this investigation.As a result a capa has been initiated.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 15GADJ LEN
• Type of Device: BIOPSY NEEDLES & TRAYS
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 7979379
• MDR Text Key: 125291262
• Report Number: 9680904-2018-00024
• Device Sequence Number: 1
• Product Code: FSH
• Combination Product (y/n): N
• PMA/PMN Number: K813338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/13/2023
• Device Catalogue Number: DIN1515X
• Device Lot Number: 0001235368
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other